EA039524B1 - Medication delivery device with sensing system - Google Patents

Abstract

Medication delivery devices are provided having a dose delivery sensing capability. A sensed element is attached to a dose setting member of the device. The sensed element includes surface features radially-spaced from one another. A rotational sensor is attached to an actuator of the device. The rotational sensor includes a movable element that is contactable against the surface features. The rotational sensor is configured to generate a signal in response to the movement of the movable element over the surface features during their rotation. A controller is operatively coupled to the rotational sensor, and in response to receiving the generated signal, the controller is configured to determine a number of the surface features passing the movable element of the rotational sensor during dose delivery. The number can be associated with an amount of dose delivered. Sensing can be provided in a module or integrated in the device.

Description

State of the art

The present invention relates to an electronic dose determination system for a drug delivery device and/or a module releasably attachable to the proximal end portion of the drug delivery device. The system for determining the delivered dose is configured to determine data for determining the amount of the drug dose delivered by the drug delivery device. Patients suffering from various diseases often need to inject themselves with a drug. In order to enable a person to conveniently and accurately self-medicate, a variety of devices have been developed, commonly known as a syringe pen or a syringe pen for injection. Typically, these pens are provided with a cartridge containing a plunger and containing a multi-dose amount of liquid medication. The drive member is movable forward to advance the piston in the cartridge to dispense the contained drug from an outlet at the distal end of the cartridge, typically through a needle. In disposable or pre-filled pens, after the pen has been used until the drug cartridge is depleted, the user discards the entire pen and begins using a new replacement pen. In reusable pens, after the pen has been used until the supply of drug inside the cartridge is exhausted, the pen is disassembled so that the used cartridge can be replaced with a new cartridge, and then the pen is reassembled for later use.

Many pens and other drug delivery devices use mechanical systems in which the elements rotate and/or move relative to each other in a manner proportional to the dose delivered by the device. Systems for measuring the relative movement of drug delivery device elements have been developed to estimate the dose delivered. However, systems integrated into a device or module to produce high volume and repeatable accuracy over the life cycle of a product have been challenging to design. In order to administer the correct amount of drug, the dose delivered by the drug delivery device must be accurate. Many pens and other drug delivery devices do not include a feature to automatically detect and record the amount of drug delivered by the device during an injection. In the absence of an automated system, the patient must manually track the amount and timing of each injection. Accordingly, there is a need for a device that can automatically determine the dose delivered by a drug delivery device at the time of injection and/or overcome one or more of these and other disadvantages of the prior art.

The essence of the invention

In one embodiment of the invention, a drug delivery device is provided, comprising a device body, a dose setting element attached to the device body and rotating relative to the device body about a rotation axis during dose delivery. The element for setting the dose contains a measured element containing surface details spaced in the radial direction at a distance from each other around the axis of rotation of the element for setting the dose. The actuator or dosing button is attached to the body of the device. The measured element rotates relative to the dispense button during dose delivery, depending on the amount of dose delivered. The rotation sensor contains a movable element in contact with the surface details of the measured element. The dosing button may be configured to accommodate a rotation sensor. The movable element is movable along the surface details during rotation of the measured element relative to the dosing button during dose delivery. The rotation sensor is configured to generate a signal in response to movement of the movable element over the surface features during rotation of the dose setting element. The controller is operatively linked to the rotation sensor and can be placed in a dosing button or module. In response to receiving the generated signal from the rotation sensor, the controller is configured to determine the number of surface features passing through the rotation sensor movable element during dose delivery. In another embodiment of the invention of the drug delivery device, the actuator has a first position in which the movable element of the rotation sensor is removed from contact with the axially extending surface parts, and a second position in which the movable element of the rotation sensor is in contact with the axially extending surface parts. details.

The actuator may be a dosing button. When the actuator is in the second position, the controller is configured, immediately after receiving a signal indicating contact with the initial first one of the axially extending surface features, to activate the controller in a full power state, and wherein the controller is configured, immediately after receiving the signal, indicating contact with a subsequent one of the axially extending surface features after the initial first surface feature,

- 1 039524 to determine the number of axially extending surface features passing through the movable element of the rotation sensor during dose delivery.

Brief description of graphic materials

Additional embodiments of the invention of this disclosure, as well as their distinguishing features and advantages, will become more apparent when referring to the description provided in this document, together with the accompanying drawings. The components in the graphics are not necessarily to scale. In addition, throughout the drawings, reference numerals designate corresponding parts throughout the various views.

In FIG. 1 is a perspective view of an exemplary drug delivery device with which the dose determination system of this disclosure operates.

In FIG. 2 is a cross-sectional perspective view of the exemplary drug delivery device of FIG. one.

In FIG. 3 is a perspective view of the proximal portion of the exemplary drug delivery device of FIG. one.

In FIG. 4 is an exploded perspective view of the exemplary drug delivery device of FIG. 1 and showing the dose determination module.

In FIG. 5 is a schematic side view, partly in cross section, of an exemplary embodiment of a dose determination system, which is illustrated attached to the proximal portion of a drug delivery device.

In FIG. 6 is a perspective view of a flange containing the element to be measured.

In FIG. 7 is a perspective view of an embodiment of the measured element.

In FIG. 8 is a schematic view of another exemplary embodiment of a dose detection system.

In FIG. 9 is a schematic view of an alternative form of the biasing element of the dose detection system.

In FIG. 10 is a schematic side view, partly in cross section, of the proximal portion of another embodiment of a drug delivery device with a dose sensing system, with the dosing button in the proximal position.

In FIG. 11 is a schematic side view, partly in cross section, of the proximal portion of the drug delivery device of FIG. 10, with the dosing button in the distal position.

In FIG. 12 is an enlarged side view of an example of a rotation sensor provided in the drug delivery device of FIG. 10, with the dosing button in the proximal position.

In FIG. 13 is an enlarged side view of the rotation sensor of FIG. 12 with dosing button in distal position.

In FIG. 14 is an axial plan view of the dose setting member showing an example of surface details.

In FIG. 15 is a schematic side view, partly in cross section, of the proximal portion of another embodiment of a drug delivery device with a dose determination system with its dosing button in the proximal position.

In FIG. 16 is a schematic side view, partly in cross section, of the proximal portion of the drug delivery device of FIG. 15 with dosing button in distal position.

In FIG. 17 is a perspective view of an example of a flange with another example of surface features along the axial surface.

In FIG. 18 is a proximal perspective view of another embodiment of a drug delivery device with a dose determination system.

In FIG. 19 is a schematic side view, partly in cross section, of the proximal portion of the drug delivery device of FIG. 18 with its dosing button in the proximal position.

In FIG. 20 is a perspective view of the proximal portion of the drug delivery device of FIG. 18 showing rotation sensor location and surface details.

In FIG. 21 is an axial plan view of the proximal portion of the drug delivery device of FIG. 18 showing rotation sensor location and surface details.

In FIG. 22 is a schematic side view, partly in cross section, of the proximal portion of another embodiment of a drug delivery device with a dose determination system with its dosing button in the proximal position.

- 2 039524

In FIG. 23 is a perspective view of another example of a flange with another example of surface features along the inner radial surface.

In FIG. 24 is an axial plan view of the proximal portion of the drug delivery device of FIG. 22 showing the arrangement of surface features.

In FIG. 25 is a perspective view of another example of a rotation sensor shown as a piezoelectric sensor.

Detailed description of the invention

In order to facilitate an understanding of the principles of this disclosure, reference will be made to embodiments of the invention illustrated in the drawings, and specific language will be used to describe them. However, it should be understood that the scope of the invention is not intended to be limited in this way.

This disclosure relates to measurement systems for a drug delivery device. In one aspect, the measuring system is for measuring the relative rotational movement between the dose setting element and the actuator of the drug delivery device in order to determine the amount of dose delivered by the drug delivery device. The measured relative rotational movements are adjusted to the amount of delivered dose. By way of illustration, a drug delivery device is described in the form of a pen. However, a drug delivery device can be any device that is used to insert and deliver a dose of a drug, such as pens, infusion pumps, and syringes. The drug may be of any type that can be delivered by such a drug delivery device. The devices described herein, such as device 10, 210, 410, 610, or 810, may further contain a drug, such as, for example, within a reservoir or cartridge 20. In another embodiment of the invention, the system may contain one or more devices including device 10 and drug. The term drug refers to one or more therapeutic agents, including, but not limited to, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, analogs glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, monoclonal antibody drugs, and any therapeutic agent that can be delivered using the above device. The drug used in the device may be formulated into a dosage form with one or more excipients. The device is actuated in the manner described above by a patient, caregiver, or healthcare professional in order to deliver a drug to a human.

An exemplary drug delivery device 10 is illustrated in FIG. 1-4 in the form of a syringe pen, configured to administer a drug to a patient through a needle. The device 10 includes a body 11 containing an elongated pen-shaped shell 12, including a distal portion 14 and a proximal portion 16. The distal portion 14 is within the cap 18 of the pen. In accordance with FIG. 2, the distal portion 14 includes a reservoir or cartridge 20 configured to hold a medicinal liquid to be dispensed through its distal outlet end during a dispensing operation. The outlet end of the distal portion 14 is provided with a removable needle assembly 22 which includes an injection needle 24 enclosed in a removable cap 25. The piston 26 is located in the reservoir 20. the time of the dose dispensing operation to push the drug substance contained therein through the needle end. The injection mechanism includes a drive element 28, for illustration, in the form of a screw, with the possibility of moving in the axial direction relative to the shell 12 to move the piston 26 through the reservoir 20.

The dose setting element 30 is connected to the sheath 12 for setting the amount of dose to be dispensed by the device 10. In the illustrated embodiment of the invention, the dose setting element 30 is in the form of a helical screw element (i.e. simultaneously moving in the axial direction and rotationally) around the longitudinal axis A-A during rotation relative to the shell 12 during dose setting and dose delivery. In FIG. 1-2 illustrates dose setting element 30 fully screwed into sheath 12 in its rest or zero position. The dose setting element 30 serves to screw proximally out of the sheath 12 until it reaches the fully extended position corresponding to the maximum dose delivered by the device 10 in a single injection. The extended position can be any position between a position corresponding to a gradually increasing extended position (for example, setting a dose of 0.5 units or 1 unit), to a fully extended position corresponding to the maximum dose delivered by the device 10 per injection, and screwing into the casing. 039524 lobe 12 in the distal direction until it reaches the initial or zero position corresponding to the minimum dose delivered by the device 10 per injection.

Referring to FIG. 2-4, the dose setting element 30 comprises a cylindrical dose setting element 32 having a screw-threaded outer surface that engages a corresponding threaded inner surface of the sheath 12 to allow the dose setting element 30 to helically rotate relative to the sheath 12. dose element 32 further comprises an inner surface with a screw thread that engages with a threaded outer surface of sleeve 34 (FIG. 2) of device 10. The outer surface of tuning element 32 contains dose indicator markings, such as numbers that are visible through the dosage window 36, to indicate to the user the set dose amount. The dose setting element 30 further comprises a tubular flange 38 that is connected to the open proximal end of the adjusting element 32 and is axially and rotationally locked on the dose adjusting element 32 by means of latches 40 received within holes 41 in the adjusting element 32. In one example, the element 30 for setting the dose further comprises an optional ring or skirt 42 located around the outer periphery of the tuning element 32 at its proximal end. Skirt 42 is axially and rotationally locked on tuning element 32 by projections 44 received in slots 46.

Therefore, the dose setting element 30 can be considered to comprise, in whole or in part, the dose setting element 32, the flange 38 and the skirt 42, since they are all fixed together in the rotational and axial direction. The dose tuner 32 is directly involved in dose setting and drug delivery control. A flange 38 is attached to the setting element 32 and, as described below, cooperates with a sleeve to selectively connect the setting element 32 to the dispensing button. As shown, skirt 42 provides a surface external to housing 11 to allow a user to rotate dose adjuster 32 to set a dose. In the embodiment of the invention illustrated in FIG. 18, the dispense button of the illustrated device 10 is a one-piece component that integrates both the skirt 42 and the dispense button 56 shown in FIG. 14. In this embodiment, the flange is attached to the tuning element and cooperates with a sleeve, described below, to selectively connect the tuning element to an integral dispense button, shown as button 656. The radial outer surface of the integral dispense button 656 provides a surface external to the body 11 devices for rotating the tuning element.

The skirt 42 illustratively includes a plurality of surface contours 48 and an annular rib 49 formed on the outer surface of the skirt 42. The surface contours 48 are illustratively longitudinally extending ribs and indentations that are arranged circumferentially around the outer surface of the skirt 42 and facilitate gripping by the user. and skirt rotation. In an alternative embodiment of the invention, the skirt 42 is removed or integral to the adjuster 32 and the user can grip and rotate the dose adjuster 32 to set the dose.

The device 10 for delivery includes an actuator 50 containing a clutch 52, which is inside the setting element 32 dose. Sleeve 52 includes an axially extending stem 54 at its proximal end. As shown, the actuator 50 further includes a dispense button 56 located proximal to the skirt 42 of the dose setting member 30. The dispensing button 56 includes a support ring 58 (FIG. 2) centrally located on the distal surface of the dispensing button 56. The support ring 58 is attached to the stem 54 of the sleeve 52, for example by interference fit or ultrasonic welding, so as to axially and rotationally lock the dispense button 56 and the sleeve 52 together.

Dispense button 56 includes a disc-shaped proximal end surface or surface 60 and an annular wall portion 62 extending distally and radially inwardly from the outer peripheral edge of surface 60 to form an annular protrusion 64 therebetween. The surface 60 of the dispensing button 56 serves as a push surface against which force can be applied manually, ie directly by the user, in order to push the actuator 50 in a distal direction. Dispense button 56 illustratively includes a recessed portion 66 centrally located on proximal surface 60, although proximal surface 60 may alternatively be a flat surface. A biasing member 68, illustrated as a spring, is positioned between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to press the actuator 50 and the dose setting member 30 axially apart. The dosing button 56 is pressed by the user to start the dosing operation. In an alternative embodiment of the invention, the skirt 42 is omitted from the device and the annular wall portion 62 of the dispense button 56 extends distally to a location approximately distal of the skirt relative to the tuning element, as shown in the figures.

- 4 039524

The delivery device 10 is configured to operate in both a dose setting mode and a dose dispensing mode. In dose setting mode, dose setting element 30 adjusts (rotates) relative to sheath 12 to set the desired dose to be delivered by device 10. Proximal adjustment serves to increase the set dose, and distal adjustment serves to decrease the set dose. The dose setting element 30 is adjusted by a rotational step (eg clicks) corresponding to a minimum gradual increase or decrease in the set dose during the dose setting operation. For example, one zoom or click may equal half or one unit of drug. The set amount of dose is visible to the user through the setting indicator markings shown through the dosage window 36 . The actuator 50, including the dose button 56 and the clutch 52, moves in the axial and rotational direction with the dose setting member 30 during adjustment in the dose setting mode.

The dose adjuster 32, flange 38 and skirt 42 (when used) are all fixed without being able to rotate to each other and rotate and extend in the proximal direction of the drug delivery device 10 during dose setting due to the threaded connection of the dose adjuster 32 to the sheath 12. During this movement, when setting the dose, the dosing button 56 is fixed without the possibility of rotation relative to the skirt 42 with the help of additional splines 74 of the flange 38 and the coupling 52 (Fig. 2), which are pressed together using the biasing element 68. In the process of setting the dose, the skirt 42 and the dispensing button 56 move relative to the shell 12 in a spiral from the start position to the end position. This rotation relative to the sheath is proportional to the dose amount set during operation of the drug delivery device 10.

Once the desired dose has been set, the device 10 is manipulated so that the injection needle 24 correctly penetrates into, for example, the user's skin. The dose delivery mode of operation is initiated in response to an axial distal force applied to the proximal surface 60 of the dispense button 56 . The axial force is applied by the user directly to the dispense button 56 . This causes an axial movement of the actuator 50 in a distal direction relative to the shell 12.

Movement in the form of an axial displacement of the actuator 50 compresses the displacement element 68 and reduces or closes the gap between the dispense button 56 and the tubular flange 38. This relative axial movement separates the mating splines 74 on the sleeve 52 and the flange 38 and thus releases the actuator 50, such as a button 56 dosing, from fixation without the possibility of rotation on the element 30 to set the dose. Specifically, the dose setting member 30 is rotatably detachable from the actuator 50 to enable the dose setting member 30 to reverse rotation with respect to the dose setting member 50 and the sheath 12. In addition, since the dose setting member 30 and the actuator 50 can freely rotate, the actuator 50 is kept from rotating relative to the device shell 12 by the user engaging the dispensing button 56 while pressing it.

As the actuator 50 continues to descend axially without rotation relative to the sheath 12, the setting element 32 is screwed back into the sheath 12 as it rotates relative to the dispensing button 56. Dose markings, which indicate the amount still left to inject, are visible through window 36. As dose setting element 30 is screwed down distally, actuator 28 is advanced distally to push piston 26 through reservoir 20 and eject drug through the needle 24 (Fig. 2).

During a dose dispensing operation, the amount of drug ejected from the drug delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50 when the setting member 32 is screwed back into the sheath 12 again. element 32 has reached the distal end of the corresponding external thread of the sleeve 34 (Fig. 2). The device 10 is then set back to the standby or zero dose position, as illustrated in FIG. 2 and 3.

The delivered dose may be obtained based on the rotation of the dose setting element 30 relative to the actuator 50 during dose delivery. This rotation can be established by detecting incremental movements of the dose setting element, which are counted as the dose setting element rotates during dose delivery.

Additional details of the construction and operation of the exemplary delivery device 10 can be found in US Pat. Another example of a delivery device is the automatic medical syringe device found in U.S. Patent No. 8,734,394 called Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing Member,

- 5 039524 which is fully incorporated into the present description by reference, while such a device is modified using one or more of the various sensor systems described herein to determine the amount of drug delivered from the device for drug delivery, based on the measurement of relative rotation within the drug delivery device. Another example of a delivery device is the reusable handle device found in US Pat. more of the various sensor systems described herein for determining the amount of drug being delivered from a drug delivery device based on measuring relative rotation within the drug delivery device.

Dosing systems use a metering component and a metering component attached to elements of a drug delivery device. The term attached encompasses any method of attaching the position of a component to another component or element of a drug delivery device so that they function as described herein. For example, the measurement component may be attached to the drug delivery device element by being placed directly on it, received within it, integrated with it, or otherwise connected to it. The connections may include, for example, connections formed by frictional engagement, splines, snap or press fit, ultrasonic welding, or adhesive.

The term directly attached is used to describe an attachment in which two components, or a component and an element, are physically attached together with no intermediate element other than the components to be attached. The fastening component may comprise a fastener, an adapter, or another part of the fastening system such as a compressible membrane inserted between the two components to facilitate fastening. Direct attachment differs from attachment in which the components/elements are connected by one or more intermediate functional elements, such as the dose setting element 32 attached in FIG. 2 to the dosing button 56 by the clutch 52.

The term fixed is used to indicate that a specified movement either can occur or cannot occur. For example, the first element is fixed in the circumferential direction with the second element if the two elements are required to move together during rotation. In one aspect, an element may be functionally fixed relative to another element rather than structurally. For example, an element may be pressed against another element in such a way that the frictional engagement between the two elements locks them together without the possibility of rotation, while the two elements cannot be locked together without pressing the first element.

This document discusses various sensor systems. In general, sensor systems comprise a measurement component and a measurement component.

The term measurement component refers to any component that is capable of determining the relative position of the component being measured. The term metering component includes a metering element or sensor along with associated electrical components for operating the metering element. A measurement component is any component for which the measurement component is capable of detecting the position and/or movement of the measurement component relative to the measurement component. For a dose determination system, the measured component rotates relative to the measuring component, which is capable of determining the rotational movement of the measured component. The measuring component may contain one or more measuring elements, and the measured component may contain one or more measuring elements. The sensor system detects the movement of the measured component and provides output signals representing the movement of the measured component. By way of illustration, a dose detection system includes an electronics package suitable for operating a sensor system as described herein. The controller is operatively connected to the sensor system for receiving output signals from one or more rotation sensors. The controller begins to receive generated signals from the rotation sensor indicating the first to last samples for the total number of samples, which is used to determine the total angular displacement. The controller may be configured to receive data indicative of the angular movement of the dose setting member, which may be used to determine from the output signals the amount of dose delivered during operation of the drug delivery device. The controller may be configured to determine from the output signals the amount of dose delivered by the operation of the drug delivery device. The controller may contain conventional components such as a processor, power supply, memory, microcontrollers, and so on. Alternatively, at least some of the components may be provided separately, for example using a computer, smartphone, or other device. Means are then provided to functionally connect the components of the external controller to the sensor system at appropriate times, such as via a wired or wireless connection.

An exemplary electronics unit 76 is shown in FIG. 5 and may include a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronic unit comprises a sensor system comprising one or more sensors operatively coupled to the processor to receive signals from a sensor representing rotation being measured. The circuit board of the electronic unit 76 further comprises a microcontroller unit (MCU) as a controller, including at least one processing core and an internal memory. The system contains a battery, such as a coin cell battery, to power the components. The electronics controller 76 includes control logic that performs the operations described herein, including determining the angular movement of dose setting components during dose setting and/or dose delivery, and/or determining the dose delivered by drug delivery device 10 drug, based on the detected rotation of the element for setting the dose relative to the actuator. Many of the components of the electronic unit may be in the chamber 78, located proximal to the button 56 dosing.

The electronics controller 76 is configured to store the total angular movement used to establish dose delivery and/or determine dose delivery to a local memory (eg, internal flash memory or an embedded electrically erasable programmable read only memory EEPROM). The controller is further operable to wirelessly transmit a signal representing the total number of readings, the total angular movement, and/or the determined dose to a coupled remote electronic device, such as a user's smartphone. The transmission may, for example, be carried out over Bluetooth low energy (BLE, Bluetooth low energy) or other suitable short or long range wireless communication protocol. As an illustration, the control logic of the BLE and the controller are integrated in the same circuit.

The dose determination system provides for determining the relative rotational movement between two elements. Whereas the degree of rotation has a known dependence on the amount of dose delivered, the sensor system functions to determine the amount of angular movement from the start of the dose to the end of the dose. For example, a typical pen dependency is that an 18° angular displacement of the dose setting element is equivalent to one dose unit, although other angular dependencies are also suitable, such as, for example, 9, 10, 15, 20, 24 or 36° may be used for some unit or 0.5 units. The sensor system is configured to determine the total angular displacement of the dose setting element during dose delivery. Thus, if the angular displacement is 90°, then this means that 5 dose units have been delivered.

Angular displacement is determined by counting increments in the number of doses when performing injections. For example, the measurement system may use a repeating pattern of the element being measured such that each repetition is an indication of a predetermined degree of angular rotation. For convenience, the structure may be set such that each repetition corresponds to the minimum dose increment that can be set by the drug delivery device.

Components of the sensor system may be permanently attached to the drug delivery device or may be detachable later. In an exemplary embodiment of the invention, at least some of the components of the dose determination system are provided in the form of a module that is detachably attached to the drug delivery device. This has the advantage that these sensor components are available for use on more than one pen. The sensor system determines during dose delivery the relative rotation of the measured component and hence the dose setting element, from which the amount of dose delivered by the drug delivery device is determined. In an exemplary embodiment of the invention, the rotation sensor is attached and non-rotatably fixed to the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the component to be measured is fixed and non-rotatably fixed to the dose setting element, which rotates relative to the actuator and device body during dose delivery. In some embodiments of the invention described herein, the component to be measured comprises an annular structure having a plurality of proximally extending protrusions located circumferentially relative to each other. The protrusions are shaped and sized to deflect the movable element of the rotation sensor. The embodiments of the invention described herein may be provided for a module that may be detachably attached to the dispense button of the delivery device or integrated into the dispense button of the delivery device, with the embodiment shown in FIG. 10-11.

With reference to FIG. 5 schematically illustrates a delivered dose detection system 80 that includes a module 82 used in combination with a drug delivery device such as device 10. Module 82 includes a sensor system, illustrated generally at 84, including a rotation sensor 86 and other related components such as processor, memory, battery, etc. Module 82 is provided as a separate component, which can be attached to the actuator with the possibility of subsequent detachment.

The dose determination module 82 includes a housing 88 attached to the dosing button 56. Housing 88 illustratively includes a cylindrical side wall 90 and a top wall 92 enclosing and sealing side wall 90. As an example, FIG. 5 schematically illustrates a side wall 90 which has inwardly projecting projections 94 attaching the module 82 to the dispense button 56. The module 82 is thus attached to the dosing button 56 so that pressing the module delivers the set dose.

Alternatively, dose determination module 82 may be attached to dispense button 56 by any suitable fastener such as a snap or press fit, threaded connection, etc., provided that in one aspect of the invention, module 82 can be removed from of the first drug delivery device and then attached to the second drug delivery device. The attachment may be anywhere on the dispense button 56, provided that the dispense button 56 can move any desired amount axially relative to the dose setting element 30, as described herein.

During dose delivery, dose setting element 30 is free to rotate relative to dispense button 56 and module 82. In an exemplary embodiment of the invention, module 82 is non-rotatably fixed to dispense button 56 and does not rotate during dose delivery. This can be provided structurally, for example, with the help of projections 94 shown in FIG. 5, or by facing splines or other surface features on the module body 88, and the dispense button 56 is engaged by axial movement of the module 82 relative to the dispense button 56. In another embodiment, distally pressing the module provides sufficient frictional engagement between module 82 and dispense button 56 to functionally cause module 82 and dispense button 56 to remain stationary together without being able to rotate during dose delivery.

The top wall 92 is spaced from the surface 60 of the dispensing button 56 and thus provides a chamber 78 containing part or all of the electronics 76. The chamber 78 defines the cavity 96 and may be open from below or may be closed by a bottom wall 98, for example. The bottom wall 98 may be positioned to rest directly on the surface 60 of the dispensing button 56. Alternatively, the bottom wall 98, if present, may be located at a distance from the dispense button 56, and other contacts between the module 82 and the dispense button 56 may be used so that the axial force applied to the module 82 is transmitted to the dispense button 56 .

Also disclosed herein is a dose determination system for determining the amount of delivered dose based on the relative rotation between the dose setting member and the body of the device. The dose detection system uses a dose setting element attached to the device body and rotatable relative to the device body about a rotation axis during dose delivery. The element to be measured is attached to the element for setting the dose and is fixed without the possibility of rotation. The actuator is attached to the device body and is kept from rotating relative to the device body during dose delivery. The element to be measured is thus rotated relative to the actuator during dose delivery, depending on the amount of dose delivered.

The dose determination system comprises a sensor system, including a rotation sensor attached to the actuator. The measured element contains surface details spaced apart in the radial direction relative to the axis of rotation of the element for setting the dose. Surface features may be arranged to correspond to the equivalent of one dose unit, although other angle relationships are also suitable, such as, for example, 9, 10, 15, 18, 20, 24, or 36° may be used for some units or 0.5 units. The rotation sensor contains a movable element attached to the actuator and having a contact part capable of resting on the surface details of the measured element and springing in their direction. The contact surface is thus positioned to move over the surface features during rotation of the element to be measured relative to the actuator during dose delivery. The rotation sensor responds to the movement of the contact part along the surface details and generates signals corresponding to the rotation of the element for setting the dose. The controller responds to the signals generated by the rotation sensor to determine

- 8 039524 dose count to determine the amount of dose delivery based on the detected rotation of the dose setting element relative to the actuator during dose delivery. Surface features can contain anything that can be detected by a rotation sensor. As previously stated, sensor systems can be based on a variety of measurable characteristics, including, for example, tactile, optical, electrical, and magnetic properties. In one aspect, the surface features are physical features that allow incremental movements to be detected as the dose setting member rotates relative to the actuator.

The contact surface is offset from the physical parts to ensure proper contact between the contact surface and the physical parts during rotation. In one embodiment of the invention, the movable element is an elastic element containing one part attached to the actuator at a location offset from the contact surface. In one example, the movable element is a follower element containing a beam attached at one end to the actuator and having a contact surface at the other end. The beam bends to push the contact surface towards the surface features. Alternatively, the movable element may be displaced in any of a variety of other ways. In addition to using an elastic beam, the displacement can be provided, for example, by means of a spring component. Such a spring component may, for example, comprise a compression, tension or torsion helical spring. In still other embodiments of the invention, the movable element can be displaced relative to the surface features of the measured element by means of a separate elastic element or spring component based on the movable element.

In one embodiment of the invention, the surface features are homogeneous features that are spaced apart around the axis of rotation of the feature being measured. In a particular aspect, the surface features are radially evenly spaced protrusions separated by intermediate depressions. The contact surface of the movable element is located in such a way as to move along the protrusions and move inward relative to the intermediate recesses. The movable element may, for example, be a resilient beam that flexes outward along the protrusions, or a moving element that rises above the protrusions.

In one aspect, the protrusions are inclined upwards in a direction opposite to the rotation of the measured element during dose delivery, to facilitate movement of the contact surface along and over the protrusions. In another aspect, the protrusions are provided with different profiles in opposite angular directions to allow detection of the direction of rotation of the measured element relative to the actuator. The protrusions may extend in any direction determined by the movable element. For example, the protrusions may extend in an axial direction or a radial direction. The axial projections may extend in a proximal direction or a distal direction. The radial protrusions may extend inward or outward. The element to be measured is attached to the element for setting the dose. Depending on the drug delivery device, the measurable element may be attached to a skirt, flange or dose adjuster, or any other component that rotates relative to the body of the device during dose delivery relative to the amount of dose delivered.

In one aspect, the measurement system of the dose detection system 80 is initially built into the drug delivery device as an integrated system. In another aspect of the invention, a modular form of a dose determination system is disclosed. The use of an attached, detachable module is particularly adapted for use with a drug delivery device in which the actuator and/or dose setting element comprises parts located outside the drug device sheath. These external portions allow the module to be directly attached to an actuator such as a dispense button and/or a measured element to be attached to a dose setting element such as a skirt, flange or dose adjuster, as described herein. Alternatively, the measured element is an integral part of the drug delivery device, and the module is attached with the possibility of subsequent detachment. This has the advantage that more complex and expensive electronics, including the rotation sensor and controller, can be reused with different drug delivery devices. In comparison, the measured element may use relatively simple parts, such as radially spaced ridges, which add little to the cost of the drug delivery device.

An exemplary drug delivery device containing an exemplary dose determination system is shown in FIG. 5-9. The device comprises a sensor system that detects surface details of a measurable element extending from one or more components of the device 30 for setting the dose, such as a tuning element 32 of the dose and/or a flange 38. In particular, the sensor system 84 of the dose determination system 80 includes a sensor 86 rotation and a measured element 99 having surface details. Prime

- 9 039524 The location and placement of surface features are shown in illustrative examples: axial surface features of the flange (for example, Fig. 6), axial surface details of the dose adjusting element (for example, Fig. 10), outer radial surface details of the dose adjusting element (for example, Fig. 20) and the inner radial surface detail of the flange (eg Fig. 23). In one example shown in FIG. 6, measurable element 99 comprises a ring 100 connected to flange 38. It will be understood that ring 100 may be permanently attached to flange 38 (shown) or dose adjusting element 32 by means of adhesive and/or fasteners, or it may be configured to be removable. attachment to a flange 38 or dose adjusting element, such as, for example, with a mechanical fastener or carrier component. The ring may be omitted, and the surface features may be integrally formed from the flange 38 or dose adjuster 32 as a single piece (shown, for example, in FIG. 17 or 23) such as, for example, by casting or additive manufacturing.

As shown in FIG. 6 and 7, the surface features 101 comprise a series of inclined projections 102. The rotation sensor 86 includes one or more movable members 103 (FIG. 5), in this case comprising a follower pin 104, which extends through a button hole 105 defined by the button surface 60 56 dispensing, and positioned so as to have a distal contact surface 111 that is capable of resting on the surface features shown as protrusions 102 as the flange 38 rotates relative to the dispense button 56. Pin 104 is shown extending through module opening 107 defined by a distal bottom wall 98 that is coaxially aligned with button opening 105. The inner surfaces that define the corresponding module opening and the button opening may be configured to provide support for the pin along two locations during its axial movement. Such a size and arrangement of holes 105, 107 can improve the linear axial movement of the pin to reduce false readings from the sensor or switch being used. More than one pin and corresponding holes defined by their respective components can be used for redundant measurement to reduce erroneous readings. The pin 104 may include a pin flange 106 located between the contact surface 111 and the dosing button 56. A coil spring 108 is positioned between the pin flange 106 and the dispense button 56 and biases the pin 104 in the distal direction of the projections 102. As the flange 38 rotates during dose delivery, the pin(s) and the dispense button maintain their relative position and the contact surface 111 of the pin 104 rises. over each surface feature, shown as ridge 102, against the biasing force of the helical spring 108. The pin 104 then drops down into each recess 110 between adjacent ridges. The pin 104 thus acts as a follower that follows the contours of the projections and recesses. The rotation sensor 86 further comprises a measuring element 114 positioned to detect movement of the pin 104 as it moves over the projections 102 and into the intermediate recesses of the PO. The sensing element 114 may take various forms capable of detecting the translational movement of the pin 104. As an example, the sensing element 114 is shown in FIG. 5 as containing a microswitch that is used to detect the axial movement of the pin 104 in the proximal direction each time the pin 104 moves over the protrusion 102. This activation will result in successive on-off or off-on settings for the microswitch for each pass of the pair. protrusion / recess of the ring 100.

In the manner described above, the rotation sensor 86 detects the angular movement of the dose setting element by counting the number of protrusions that trigger the measuring element 114 during dose delivery. The rotation sensor 86 generates signals indicative of this angular movement, and these signals are used by the controller to determine the total rotation of the dose setting element during dose delivery, which can be used to determine the amount of dose delivery. In one example, the rotation sensor 86 generates signals indicating the number of samples, and the controller receives the generated signal. The controller may store the number of readings in internal memory and/or electronically transmit the number of readings to an external device. The controller can compare the number of readings with an internal database that matches the number of readings with the total angular movement and hence the delivered dose. The determined angular movement and/or delivered dose may be displayed on a local display or indicator system (such as numbers) as part of an electronic package and/or transmitted electronically to an external device.

In FIG. 8 shows alternative dose detection systems that similarly use radially spaced ridges 102 and sliders 103 that include pins 104 that move along successive ridges and depressions. As shown in FIG. 8, each movable member 103 includes a contact surface 116 that moves over surface features 101 that are radially spaced around an axis of rotation, such as projections 102. Contact surface 116 of pin 104 is shown in FIG. 8 as comprising an enlarged end portion 118, which may desirably be made of a strong, low friction material that allows the pin 104 to easily slide over the projections 102. The enlarged end portion 118 has a cross-sectional area greater than the cross-sectional area pin. Also, as shown in FIG. 8, the protrusions 102 may be formed with a surface 120 that is inclined upward in a direction opposite to the direction of rotation shown by arrow 122 of the dose setting element. This further facilitates the movement of the follower over the projections.

In another aspect, the opposite side of the projections 102 may be tilted to allow the dose setting member to rotate in the opposite direction. In addition, the two sides of the protrusions can be provided with different angles of inclination to allow the dose determination system to determine the direction of rotation. On the other hand, opposite sides of the projections may be inclined more steeply to prevent rotation in the other direction.

This document describes an embodiment of the invention in which the actuator moves distally relative to the body of the device to transition from dose setting mode or from rest to dose delivery mode. In the proximally displaced state, the follower elements can be separated from the projections as one way to allow rotation of the measured element relative to the actuator in the opposite direction of dose delivery. However, as also described, in certain embodiments of the invention, the actuator is non-rotatably attached to the dose setting member during dose setting.

In FIG. 8 shows an alternative dose detection system that works by detecting vibrations associated with the rotation of the measuring element relative to the actuator during dose delivery. When the measuring element 99 rotates in the direction 122 relative to the moving element 103, the contact surface 116 moves the pin 104 away from the element for setting the dose and against the biasing element, for example, the spring 108. Once the contact surface 116 passes over the top of the protrusion, the biasing element quickly pushes the follower element into the subsequent recess 110. Referring to FIG. 8, with additional movement of the measured element 99 in the direction 122, the spring 108 will drive the pin 104 down into the recess 124, where it will be abruptly stopped upon contact with the bottom of the next recess 124. This abrupt stop will be accompanied by a oscillation that is detected by the rotation sensor.

For example, in FIG. 8 shows a support 126 attached to the proximal end of a pin 104 and carrying a rotational accelerometer 128. The rotation accelerometer 128 is provided primarily to detect vibrations indicative of rotation of the element being measured. During operation of the system, the accelerometer 128 detects each vibration associated with the passage of the pin 104 over the top of the protrusion and falling into the subsequent recess. The accelerometer 128 may be of any type capable of detecting vibration, and in a particular aspect includes a 3-axis accelerometer. In the present description, this accelerometer is referred to as a rotation accelerometer to distinguish it from an accelerometer used to detect the rotation of the element being measured, rather than offering a specific type of accelerometer. Other sensors capable of detecting rotational vibrations may also be used. Also in FIG. 8 shows optional sensor components, including a second support 130 and a second accelerometer 132, which are useful in combination with a rotational accelerometer 128. The second accelerometer used herein is referred to as a background accelerometer to distinguish it from an accelerometer used to detect background fluctuations, and not to suggest a specific type of accelerometer. The background accelerometer 132 is provided primarily to detect background oscillations, such as those caused by movement of the entire drug delivery device, which oscillations do not indicate rotation of the element being measured. For this purpose, background accelerometer 132 is relatively isolated from pin 104, such as pin 104 slid into a hole in dispense button 56 .

Significant axial movement of the pin 104 relative to the dispense button 56 will be felt more strongly with the rotation accelerometer 128 than with the background accelerometer 132. will be indicated. For comparison, if the amount of oscillation detected by the rotational accelerometer is significantly greater than that detected by the background accelerometer at a given time, then the rotation of the element being measured is indicated. The controller compares the detected rotational oscillations and background oscillations to identify oscillations indicative of rotation of the measured element relative to the actuator during dose delivery.

The action of the follower during the rotation of the measured element can also be associated with associated sounds. In particular, a distinctive sound will be produced when the pin 104 hits the bottom of the recess 124. An alternative dose determination system uses this sound to determine the rotation of the measured element 99 relative to the dispense button 56. As an example, also shown in FIG. 8 is a microphone 134 that forms a component of an alternative measurement system. Upon detection of a sound preset as an indication of the rotation of the measurand, the rotation sensor generates a signal identifying the rotation of the measurand associated with dose delivery. An optional background sound microphone can be used to distinguish between rotational sounds and other sounds.

As shown in FIG. 8, the follower can be displaced, for example, by a helical spring. Alternatively, the follower may be biased towards the surface features in various other ways. For example, a resilient element may be used to bias the pin 104 against the protrusions 102. As shown in FIG. 9, the elastic member 136 is attached at one end to the underside 138 of the dispensing button 56. The resilient element 136 includes a portion 140 at the opposite end abutting against the enlarged end portion of the contact surface 116 of the pin 104. Movement of the contact surface 116 over the projections causes the pin to move upward towards the downwardly directed elastic element 136 and thus the contact surface 116 is maintained in position against the surface features . By way of illustration, instead of the pin 104, the follower may comprise a resilient member 136, and the contact surface may be located on the end portion 140. Referring now to FIG. 1-2, which show a drug delivery device equipped with a measuring system, which is further described as being used to determine the amount of dose set during device operation. This amount is determined based on the measurement of relative rotational movements during dose setting between the elements of the drug delivery device, where the measured movements are brought into line with respect to the amount of dose set. In various embodiments of the invention, the measuring system is configured to determine the amount of at least one of the set dose and the delivered dose when the device is operated, or, alternatively, both the amount of the set dose and the amount of delivered dose when the device is operated.

In FIG. 10-11 illustrates the proximal portion of the device, now referred to as 210, with the dose sensor system 284 located within the dispense button 256 rather than the module and containing the rotation sensor 286. The device 210 contains many of the same dose setting and dose delivery components as described with respect to the device 10, including at least a portion of the electronic components in the electronic assembly, and such components will have the same respective descriptions. Although the device 210 is shown as a device in an integrated dose measurement metering system, such a metering system may be built into a module for detachable attachment to a dispense button.

The dose setting element 230 is connected to the device sheath 212 to set the amount of dose that will be dispensed by the device 210. The dose setting element 230 serves to screw proximally out of the sheath 212 until it reaches the fully extended position corresponding to the maximum dose. delivered by device 210 in a single injection. The cylindrical dose setting element 232 of the dose setting element 230 comprises a screw-threaded outer surface that engages a corresponding threaded inner surface of the sheath 212 to allow the dose setting element 230 to spirally rotate relative to the sheath 212. The dose setting element 232 includes an internal surface with a screw thread that engages with the threaded outer surface of the device sleeve 210, such as sleeve 34 in FIG. 2. On the outer surface of the adjusting element 232, dose indicator markings are applied, which are visible through the dosage window 236, to indicate to the user the set dose amount. The tubular flange 238 of the dose setting element 230 is connected to the open proximal end of the adjusting element 232 and is axially and rotationally locked on the dose adjusting element 232 by means of latches received within holes in the adjusting element 232, such as, for example, shown in FIG. 2.

The actuator 250 of the delivery device 210 includes a sleeve 252 that resides within the dose adjuster 232. The proximal end of the sleeve 252 includes a stem 254 that extends axially from its proximal end. As shown, the dispensing button 256 of the actuator 250 is located in the proximal direction of the element 230 to set the dose. The support ring 258 of the dispense button 256 is attached to the stem 254 of the sleeve 252, for example by interference fit or ultrasonic welding, so as to axially and rotationally lock the dispense button 256 and the sleeve 252 together. in the form of a spring, is located between the distal surface of the support ring 258 of the dose button and the proximal surface of the tubular flange 238 of the dose setting element to press the actuator 250 and the dose setting element 230 axially from each other. The dispense button 256 is pressed by the user to start the dispense operation. The bias member 268 biases the dispense button 256 to a proximal first position (as shown in FIG. 10) where it remains during the dose setting operation until the user applies an axial force large enough to overcome the bias force of the member 268 to move dosing buttons 256 to a distal second position (as shown in FIG. 11) for a dose dispensing operation.

Dispense button 256 includes an upper proximal wall 261 with a disc-shaped proximal end surface 260 and an annular wall portion 262 extending distally from proximal wall 261 to define a button shell cavity 265. The surface 260 of the dispensing button 256 serves as a push surface against which force can be applied manually, ie directly by the user, to push the actuator 250 in a distal direction. The dispensing button 256 includes a distal wall 263 axially spaced apart from the proximal wall 261. The distal wall 263 may at least partially divide the cavity 265 into two parts of the cavity, namely the proximal and the distal. The support ring 258 of the dispensing button 256 is shown extending distally from the intermediate location of the distal wall 263 for attachment with the stem 254 of the coupling 252. In one example, the surface features 301 are located in the cavity 265 in the radial direction outside the biasing element 268. As shown, the rotation sensor and the controller located inside the cavity 265.

The distal wall 263 may be configured to allow a portion of the sensing system to extend distally past the distal wall 263. The distal wall 263 may comprise a discrete opening or may extend partially through the cavity 265 from a portion of the annular wall portion 262 to stop at the opposite end of the annular wall portion to form an axial hole 269 as shown in FIG. 10-11. Axial hole 269 may be positioned radially from axis A-A towards the outer end such that a rotation sensor that passes through hole 269 is positioned over surface features 301 that are radially spaced about axis of rotation A-A. . The electronics unit 276 is shown housed within the dosing button 256. The circuit board 325 contains a plurality of electronic components and is shown mounted on the proximal surface of the distal wall 263. Sensor system 284 includes a rotation sensor 286 operably coupled to the circuit board controller processor to receive signals from the sensor representing measured rotation. The rotation sensor 286 is shown mounted on the distal surface of the circuit board. The controller of the electronic unit 276 contains at least one processing core, electrically connected with the sensor 286 rotation and internal memory. Block 276 contains a battery B, illustrating a coin cell battery, for powering the electronic components. The controller includes control logic that performs the operations described herein, including determining the dose delivered by the drug delivery device based on the detected rotation of the dose setting element relative to the actuator. Some of the components in the electronics unit 276 are shown as unconnected for illustrative purposes only and are actually electrically connected to each other, such as by connectors, wires, or conductors, as is understood in the art, such as shown at 297 in FIG. 10 and illustrated in other figures.

Sensor system 284 with rotation sensor 286 is configured to detect surface features 301 extending from one or more components of dose setting device 230, such as dose adjuster 232 (as shown) and/or flange 238. For example, with reference to FIG. . 14, the axial end surface 233 of the dose setting element 232 of the ring-shaped dose setting device 230 can define surface features 301, shown as projections 302 spaced radially apart along the axial end surface, the projections being separated by intermediate recesses 310. In the shown example, there are eighteen ledges, each of which is located at a distance of 20 degrees from the neighboring ones.

The dispense button 256 is movable relative to the device shell 212 between two positions. In FIG. 10, the dispense button 256 is in a proximal position where the device is in the first dose setting operating mode in which the dispense button can be used to set a dose. In FIG. 11, the dispense button 256 is in a distal position where the device is in a second dose delivery operating mode in which the dispense button can be used to deliver a dose. In certain embodiments, the dispense button 256 is non-rotatably attached to the dose setting element in dose setting mode, and the dispense button 256 can be rotated to set the dose. In this position, the rotation sensor 286 is axially displaced from the surface features 301. In dose set mode, the rotation sensor 286 may remain inoperative and the electronics may remain off or in a low power state.

When the proximal wall 261 is depressed, the dispense button 256 is pushed forward in a distal direction with respect to the sheath 212, compressing the spring 268, as shown in FIG. 11. A long press of the dispensing button 256 in the distal direction causes the dose adjusting element 232 to spiral back with respect to the sheath 212. As a result, the dose adjusting element 232 and the flange 238 are driven by the axially moving dispensing button. The dose determination system can only work for counting when the dispense button is pressed. The electronics may include a clock or timer to determine the elapsed time between readings activated by triggering a rotation sensor from the surface features of the element being measured. When the trigger lever is not activated, that is, the controller does not

- 13 039524 detected readings over a period of time, this can be used to indicate that a dose has been completed. When measuring the initial one of the surface features 301, the controller is configured to cause the electronic unit 276 to wake up or activate to a higher or full power state. The activation of the wake-up function is configured to allow power transfer from the power source (shown as a battery) to power up the dose measurement electronics to minimize inadvertent loss of power or use when a dose event is not occurring. In other embodiments, a separate wake-up switch may be provided and placed within the dispense button shell and will operate when the dispense button 256 is in its distal position. In this case, the wake-up switch may be located, for example, along the upper end of the flange. Upon activation of the electronics, the controller begins to receive generated signals from the rotation sensor indicating counts from first to last for the total number of counts, which is used to determine the total angular displacement and thus the amount of delivered dose.

In FIG. 12-13 depict one example of a rotation sensor 286 provided in device 210. For example, rotation sensor 286 includes a sensor body 320 and a movable member including a pair of contacts 324, 326. Contacts 324, 326 may be resilient, which have a natural configuration in one state. and can move or deviate to another state under the force and return to the natural configuration when the force is removed. Sensor housing 320 is shown mounted on circuit board 325 and is operatively coupled to the electronics controller and configured to signal the sensor's electronic characteristic (voltage, resistance, current signal) determined by contacting or separating contacts 324, 326 to the controller. Contacts 324, 326 can remain spaced apart in a natural state until they come into contact with each other in operation by deflecting at least one of the contacts (shown as contact 326) during engagement with surface features 301. Alternatively, both of the contacts 324, 326 may be configured to deflect when engaging with surface features and contacting each other due to deflection. Upon engagement of contact 326 with surface feature 301, contact 326 may return to its natural state when it is in spaced relationship with contact 324. Alternatively, contacts 324, 326 may remain in contact with each other in a natural state and are configured to the ability to separate from the contact relationship due to engagement with the surface features 301 and return to their natural state in their contact relationship after passing through the surface feature. According to FIG. 12, the rotation sensor 286 is in its proximal position when the dispense button 256 is in its proximal position, where the device is in its first operating dose setting mode. According to FIG. 13, the rotation sensor 286 is in the distal position when the dispense button 256 is in its distal position, where the device is in its second operating dose delivery mode.

In FIG. 12-13 illustrate an example of a pin configuration 324, 326, although other pin configurations may be used. The first contact 324 is shown extending axially from the sensor body 320. The first contact 324 includes a first segment 330 connected to the sensor body 320 and a second segment 332 extending from the first segment 330. The first segment 330 is shown extending axially from the sensor body 320 and the second segment 332 is shown extending radially from the first segment. 330 when connected at an angle. Second contact 326 includes a first segment 340 connected to sensor housing 320 and a second segment 342 extending from first segment 340. First segment 340 is shown extending axially from sensor housing 320. The second segment 342 is shown extending generally in a radial direction from the first segment 340 when connected at an angle. The second segment 342 includes a lever portion 344, a transition engagement portion 346, and an end contact portion 348 connected in series with the first segment 340. The lever portion 344 is sized and shaped to accommodate the end contact portion 348 under the second first contact segment 332. Lever portion 344 is shown extending obliquely in the axial and radial directions from first segment 342. Transitional engagement portion 346 is configured to engage directly with surface member 301. Transitional engagement portion 346 may be U-shaped, V-shaped, or obliquely shaped to transition the second segment 342 from the distal direction to the proximal direction. The end contact portion 348 extends in the radial direction and may be generally parallel and spaced apart from the second segment 332 of the first contact 324 in its natural state. The shape of the interface interface 346 can provide sliding contact along the surface features 301 without causing the rotating dose adjuster to jam. The shape depth of the transition engagement portion 346 is sized such that, on its distal surface engaging with the surface features 301, the second contact 326 flexes in the proximal direction at an angle with the first segment to accommodate the proximal surface of the end cone.

- 14 039524 stroke part 348 in contact with the distal surface of the second segment 332 of the first contact 324. Such contact is sufficient to generate a signal of the electronic characteristics of the sensor. Alternatively, one of the contacts may be used, such as contact 326, and the surface features may have an electrically conductive property, such as being coated with a metallic material, so that upon interaction between the contact and the surface feature, the rotation sensor may generate a signal as described herein.

In FIG. 15-16 depict the proximal portion of the device, now designated 410. Device 410 includes many of the same dose setting and delivery components as described with reference to device 10 or 210, including at least a portion of the electronic components in the electronic block for the dose determination system, and such components will have the same corresponding descriptions. Although the device 410 is shown as a device in an integrated metering system, such a metering system may be built into a module for detachable attachment to a dispense button. Device 410 may have the same device components as device 210, such as, for example, device sheath 412, dose adjustment element 432, flange 438, and electronics 476, except for a different configuration of the rotation sensor and a different mounting element. doses with surface details used for measurement, as will be described below. As shown, the rotation sensor and controller are located within the button cavity.

Another example of a rotation sensor, designated generically as 486, of a dose determination sensor system 484 can be used with any module and/or device described herein. For example, the rotation sensor 486 is a microswitch including a sensor body 490 and a movable member containing a trigger lever 492. end so that the actuating lever 492 of the rotation sensor 486 extends to be positioned over the surface features 501 that are radially spaced about the rotation axis A-A. The actuating lever 492 is biased by the internal spring to the natural state until a force overcomes it to push the actuating lever 492 to a position other than the natural state position to the operating state. Sensor housing 490 is shown mounted on circuit board 525 and is operatively coupled to the electronics controller and configured to signal the sensor's electronic response (voltage, resistance, current signal) determined by moving the actuating levers to the controller. The trigger lever 492 may remain in its natural state until it is returned to engage with the surface features 501. Following the interaction between the trigger lever 492 and the surface feature 501, the trigger lever 492 may return to its natural state. According to FIG. 15, the rotation sensor 486 is in a proximal position when the dispense button 456 can be moved to its proximal position, where the device 410 is in its first operating dose setting mode. A bias member (not shown) may be positioned axially between the dispensing button and the dose setting member, and the surface features 501 are positioned radially outside the bias member as shown in FIG. 10-11. According to FIG. 16, the rotation sensor 486 is in the distal position when the dispense button 456 is in its distal position, where the device is in its second operating dose delivery mode.

In FIG. 17 shows one example of a dose setting element having surface features 501. In one example, the axial surface 437 of the proximal end of flange 438 may be entirely defined with surface features shown as projections 502 with intermediate recesses 510, such as a molded part or a part made with using additive manufacturing. In another example, an annular component with surface features defined along one of its surfaces may be connected to the axial surface of a flange. It is understood that the ring may be permanently or temporarily attached to the flange with adhesives and/or fasteners. In another example, surface features are formed from or otherwise associated with a dose adjusting element.

As shown in FIG. 15-17, the surface features 501 comprise a series of protrusions 502, each of which has an oblique shape. The protrusions 502 may be formed with a surface that slopes upwards in a direction opposite to the direction of rotation indicated by arrow 511 of the flange 438. This further facilitates movement of the actuating lever 492 over the protrusions 502. to set the dose in the opposite direction. In addition, the two sides of the protrusions 502 may be provided with different angles of inclination to allow the dose determination system to determine the direction of rotation. On the other hand, opposite sides of the projections 502 may be inclined more steeply to prevent rotation in the other direction.

The following embodiments of the invention illustrate various arrangements of the rotation sensor and surface features along the radial direction. In FIG. 18-21 shows the proximal portion of the device, now referred to as 610, showing the rotation sensor of the detection system.

- 15 039524 dose divisions, located in the radial direction outward relative to the surface features that extend in the radial direction outward. The device 610 includes many of the same dose setting and dose delivery components as described with respect to device 10, 210, or 410, including at least a portion of the electronic components in the electronic package for the dose determination system, and such components will have the same relevant descriptions. Although the device 610 is shown as a device in an integrated metering system, such a metering system may be built into a module for detachable attachment to a dispense button. Although the rotation sensor is shown as a microswitch, which is similar to that shown in FIG. 15, the rotation sensor may be any of the sensors described herein. Device 610 may have the same device components as device 210, such as device sheath 612, dose adjuster 632, flange 638, and electronics 676, for example, except with regard to a different rotation sensor configuration and different mounting element. doses with surface details used for measurement, as will be described below.

The rotation sensor 686 of the sensor system 684 is shown along the annular wall portion 662 of the dispense button 656 . The sensor housing 690 of said rotation sensor 686 may be located in the opening 695 defined by the annular wall portion 662, or alternatively, the sensor housing 690 may be located along the inner surface of the wall portion 662. The movable member includes a trigger 692 that extends in the radial direction inward to the longitudinal axis AA. Although not shown, the rotation sensor 686 is operatively coupled to the electronics controller, such as through electrical conductors connected between the sensor 686 and the circuit board, which extend along the inner surface of the dispense button shell. The rotation sensor 686 is configured to transmit the sensor's electronic characteristic signal (voltage, resistance, current signal) determined by moving the trigger of the rotation sensor 686 to the controller.

In FIG. 19-21 shows a flange containing surface details. In one example, the outer radial surface 639 of the proximal annular end 641 of the flange 638 may be entirely defined with surface features 701 that are radially spaced about the axis of rotation and shown as radial projections 702 with intermediate recesses 710, such as a molded part or a part made with using additive manufacturing. In another example, an annular component with surface features 701 defined along the outer radial surface may be connected to the axial surface of the flange. It is understood that the ring may be permanently or temporarily attached to the flange with adhesives and/or fasteners. In another example, surface features 701 are formed from or otherwise associated with a dose adjusting element. The surface features may comprise a series of slanted ridges, as previously described. Radial projections 702 may extend between the proximal end and the distal end to form axial ribs. In FIG. 18-19 illustrate the rotation sensor in the proximal position when the dispense button 656 is in its proximal position, where the device 610 is in its first operating dose setting mode. The dispense button 656 can be moved to its distal position (referring to FIGS. 20-21) to place the rotation sensor in the distal position where the device is in its second dose delivery operating mode. In one example, the trigger lever 692 may enter through one of the recesses 710 from the proximal end when the dispense button is moved to its distal position such that the trigger lever engages surface features. The controller is able to count how many times the trigger lever is moved between the first trigger and the last trigger, and such data is used to determine the dose delivery.

In FIG. 22 shows the proximal portion of the device, now referred to as 810, showing a rotation sensor positioned radially inward relative to surface features that extend radially inward. The device 810 includes many of the same components that function to set the dose and deliver the dose as described with reference to the device 10, 210, 410, or 610, including at least a portion of the electronic components in the electronics assembly for the dose determination system 844, and such the components will have the same corresponding descriptions. Although the device 810 is shown as a device in an integrated metering system, such a metering system may be built into a module for detachable attachment to a dispense button. Device 810 may have the same device components as device 210, such as device sheath 812, dose adjuster 832, dispense button 856, flange 838, and electronics 876, for example, except for a different rotation sensor configuration and another element for setting the dose with surface details used for measurement, as will be described below.

Like the location of the rotation sensor 286, the rotation sensor 886 is shown extending from the distal surface of the circuit board through the axial hole 869. The sensor housing of said rotation sensor 886 is mounted on the circuit board and is operatively coupled to the electronics controller 876 and configured to transmit a sensor electronic characteristic signal ( voltage, resistance, current signal) determined by the movement of the movable element, which contains the trigger lever of the rotation sensor 886, towards the controller. Rotation sensor mount 886 is configured to place its trigger lever on the periphery of the proximal annular end

841 of flange 838 and faces radially outward to engage surface features 901.

In FIG. 23-24 shows a flange 838 containing surface details. In one example, the inner radial surface 839 of the proximal annular end 841 of the flange 838 may be entirely defined with surface features 901 that are radially spaced about an axis of rotation and shown as projections 902 with intermediate recesses 910, such as a molded part or a part made with using additive manufacturing. In another example, an annular component with surface features defined along the outer radial surface may be connected to the axial surface of the flange. It is understood that the ring may be permanently or temporarily attached to the flange with adhesives and/or fasteners. In another example, surface features 901 are formed from or otherwise associated with a dose adjusting element. Surface features 901 may include a number of slanted projections. The surface features may extend between the proximal end and the distal end to form an axial rib.

In FIG. 25 illustrates a rotation sensor as a piezoelectric sensor 1000 that can be used with any of the devices 10, 210, 410, 610, or 810. The piezoelectric sensor 1000 can be oriented similar to the rotation sensors described above, for example, axially, radially outward. or radially inwards. In one example, the actuating lever 1002 of the piezoelectric sensor 1000 is formed as a film of piezoelectric material that is bendable. The film extends from the sensor body 1004, and the sensor body 1004 includes a first electrode 1006 and a second electrode 1008. The sensor body may comprise a molded polymer sheath, such as, for example, a fluoropolymer (e.g., polyvinylidene fluoride) or polyurethane. The piezoelectric sensor 1000 is a transducer that converts mechanical energy into electrical energy. More specifically, the piezoelectric sensor 1000 converts the mechanical deformation of the actuating lever 1002 into a proportional electrical signal (charge or voltage). Thus, when the trigger lever 1002 of the piezoelectric sensor is subjected to mechanical stress and subjected to deformation or stretching, the piezoelectric sensor 1000 is configured to generate a proportional electrical signal between the first electrode 1006 and the second electrode 1008 for detection by the electronics analog voltage detector. The mechanical deformation of the trigger 1002 of the piezoelectric sensor 1000 may be resilient so that the trigger 1002 may return to its original, natural shape when the force is released.

The electronics controller may be configured to receive an analog piezoelectric signal from the voltage detector of each piezoelectric sensor 1000, which may be a substantially ring signal. The electronics controller may be programmed to convert an analog piezoelectric signal to a digital signal, such as, for example, an intermediate digital signal, which may be a high frequency signal that represents the time of a click or warp event. The electronics controller may be further programmed to convert the intermediate digital signal to a conventional digital signal, which may be a single step/square wave with a predetermined width W representing a predetermined time, as described further below.

Signal processing logic for use by the control system. The logic subjects the analog piezoelectric signal to a DC (direct current) bias stage using resistors, then an amplification stage using an amplifier, and then an A/D conversion stage using a comparator to generate an intermediate digital signal. The signal may be generated when the input voltage is at or above a preset voltage (eg 1.3V). Alternatively, the signal may be ignored when the input voltage is less than the preset voltage. The intermediate digital signal can be converted to a conditional digital signal by turning the signal on when the timer is initiated in the timer initiation step and turning the signal off when the timer expires after a predetermined time has elapsed in the timer expiration step. The timing steps may be performed using a RC (resistancecapacitance) timing loop. The preset timing associated with the timing steps can control the width W of the conditional digital signal and can be adjusted to match the timing of each rotation and warp event to minimize errors. The logic can output a number corresponding to the number of digital signals counted during a certain period of time.

Devices described in this document, such as, for example, devices 210, 410, 610 or 810,

- 17 039524 may contain a system for determining the dose, including the determination of the relative rotational movement between the two elements. Whereas the degree of rotation has a known dependence on the amount of dose delivered, the sensor system in any embodiment of the invention functions to determine the amount of angular movement from the start of the dose to the end of the dose. Angular displacement is determined by counting increments in the number of doses when performing injections. For example, the measurement system may use a repeating pattern of the element being measured such that each repetition is an indication of a predetermined degree of angular rotation. For convenience, the structure may be set such that each repetition corresponds to the minimum dose increment that can be set by the drug delivery device. The controller is configured to count the number of generated signals. The count can be transferred electronically to an external device. The external device described herein may refer to a server, mobile phone, or other known computer systems. The count may be related to the absolute angle of rotation, which is then used by the processor of the external device to determine the amount of delivered dose. The signal generated by the initial contact of the contacts can be used to wake up or activate the controller, as described earlier. As described above, any of the rotation sensors described herein, such as rotation sensors 286, 486, 686, 886, detects the angular movement of the dose setting element by counting the number of surface features that trigger activation of the trigger during dose delivery. Each of the rotation sensors generates signals indicative of this angular movement, and these generated signals are used by the electronics controller to determine the total number of samples or units. This total number of counts corresponds to the total rotation of the dose setting element during dose delivery and thus the amount of dose delivery. In one example, each of the rotation sensors generates signals indicating the number of samples, and the controller receives the generated signal. The controller may store the number of samples within the device in internal memory and/or transmit the number of samples to an external device. The controller can compare the number of counts with an internal database that matches the number of counts with the total angular movement. The determined angular movement may be displayed on a local display and/or transmitted to an external device.

Devices described herein, such as, for example, devices 210, 410, 610, or 810, may include the wake-up function described herein, in which pressing the dispense button to its distal position during the start of dose delivery can activate the controller. . For example, immediately after measuring an initial one of the surface features, the electronics controller is configured to cause the electronics to wake up or wake up to a full power state. The activation of the wake-up function is configured to allow power transfer from the power source (shown as a battery) to power up the dose measurement electronics to minimize inadvertent loss of power or use when a dose event is not occurring. In other embodiments, a separate wake-up switch may be provided and placed within the dispense button shell of any of the devices described herein and will operate when the dispense button is in its distal position. In this case, the wake-up switch may be located, for example, along the upper end of the flange.

In some embodiments of the invention, a single measuring system may be used for both measuring dose detection and wake-up activation. For example, the devices described herein, such as, for example, devices 210, 410, 610, or 810, may have a controller configured, immediately after measuring the initial first surface feature, to wake up or wake up the electronic unit to a full power state. Subsequently, the controller is configured, immediately after measuring the first surface feature (or second in order) after the initial first surface feature, to count the total number of surface features until the rotation of the dose setting element is stopped after the dose delivery phase is completed. One advantage of a single system with this extensive functionality is that it can reduce the number of electronic components in a device, as well as the complexity of manufacturing with additional sensors.

The device shown is a reusable pen-shaped drug injection device, typically for manual administration, with which the user selectively sets a dose and then injects that set dose. Injection devices of this type are well known and the description of the device is merely illustrative as the measuring system can be adapted for use in various configurations of drug delivery devices, including pen-shaped drug injection devices of various designs, injection devices of various shapes and infusion pumps. The drug may be of any type that can be delivered by such a drug delivery device. The device is intended to be illustrative and not restrictive, as the measurement system described below may be used in other devices of various designs.

To clarify usage and thereby provide a notice to the public, the phrases are at least one of <A>, <B>, ... and <N>, or at least one of <A>, <B>, ..., <N> or combinations thereof, or <A>, <B>, ... and/or <N> are defined by the applicant in the broadest sense, replacing any other implied definitions given above or below, unless otherwise expressly stated by the applicant, and mean one or more elements selected from the group containing A, B, ... and N. In other words, the phrases mean any combination of one or more of the elements A, B, ... or N, including one single element or one element in combination with one or more other elements, which may also contain additional elements not listed in combination. Although various embodiments of the invention have been described, it should be apparent to those skilled in the art that many more embodiments and embodiments of the invention are possible. Accordingly, the embodiments of the invention described herein are examples, and not the only possible embodiments and embodiments of the invention. In addition, the advantages described above are not necessarily the only advantages, and it is not necessary to expect that all the advantages described will be achieved with each embodiment of the invention.

This disclosure describes various aspects, which include, but are not limited to, the following aspects:

1. A drug delivery device, comprising: a device body; a dose setting member attached to the device body and rotating relative to the device body about a rotation axis during dose delivery; a measurable element attached to the dose setting element and fixed thereon without the possibility of rotation, and the specified measurable element contains axially extending surface features spaced radially from each other around the axis of rotation of the dose setting element; an actuator attached to the body of the device, wherein the measured element is rotatable relative to the actuator during dose delivery depending on the amount of dose delivered; a rotation sensor attached to the actuator, wherein the rotation sensor comprises a movable element in sliding contact with axially extending surface features during rotation of the measured element relative to the actuator during dose delivery, the rotation sensor being configured to generate a signal in response to actuating the movable element over the axially extending surface features during rotation of the dose setting element; and a controller operatively associated with the rotation sensor, wherein, in response to receiving a generated signal from the rotation sensor, the controller is configured to determine the number of axially extending surface features passing through the rotation sensor movable member during dose delivery.

2. The drug delivery device according to aspect 1, characterized in that the axially extending surface features contain alternating protrusions and recesses, while the movable element rests on the protrusions and recesses during rotation of the measured element relative to the actuator during dose delivery.

3. The drug delivery device of claim 2, wherein the projections extend proximally from the dose setting element. 4. The drug delivery device according to any one of aspects 1-3, characterized in that the dose setting element is a flange or dose setting element.

5. The drug delivery device according to any one of aspects 1-4, characterized in that the rotation sensor comprises a switch, while the movable element, alternately entering into interaction or out of interaction with axially extending surface features, is configured to be brought into switch action and signal generation.

6. The drug delivery device according to any one of aspects 1-5, characterized in that the actuator has a first position in which the movable element of the rotation sensor is removed from interaction with axially extending surface features.

7. The drug delivery device according to aspect 6, characterized in that the actuator has a second position in which the movable element of the rotation sensor contacts axially extending surface parts.

8. The drug delivery device according to aspect 7, characterized in that, when the actuator is in the second position, the controller is configured, immediately after receiving a signal indicating contact with the initial first one of the axially extending surface features, to activate the controller in full power state, wherein the controller is configured immediately after receiving a signal indicating contact with a subsequent one of the axially extending surface features after the initial first

- 19 039524 surface details, determine the number of axially extending surface details passing through the movable element of the rotation sensor during dose delivery.

9. The drug delivery device according to any one of the aspects 1-8, characterized in that the movable element comprises at least one contact, with which, immediately after engaging with the axially extending surface features, a signal can be generated.

10. The drug delivery device according to aspect 9, characterized in that at least one contact contains a pair of contacts, which, immediately after the entry into the interaction of one of the pair of contacts with an axially extending surface, are made movable into contact with another of the pair. contacts to generate a signal.

11. The drug delivery device according to any one of aspects 1-8, characterized in that the movement of the movable element relative to the axially extending surface features is configured to generate rotational vibrations, while the rotation sensor is configured to generate a signal in response to detection of rotational fluctuations.

12. The drug delivery device of claim 11, wherein the rotation sensor comprises a rotation accelerometer operable to detect rotational vibrations.

13. The drug delivery device according to aspect 12, characterized in that the rotation sensor further comprises a background accelerometer operating to detect background vibrations, wherein the controller is configured to compare rotational and background vibrations and is configured to determine from said comparison of vibrations indicating rotation of the measured element relative to the actuator during dose delivery.

14. The drug delivery device according to any one of aspects 1-8, characterized in that the movement of the movable element relative to the axially extending surface features is configured to generate sounds during rotation, while the rotation sensor is configured to generate signals in response to detection sounds during rotation.

15. The drug delivery device according to any one of aspects 1-14, further comprising a module detachably attachable to the actuator, the module comprising a movable element for engagement with a measured element of the dose setting element of the device body, which is located outside the module .

16. The drug delivery device of any one of aspects 1-8, wherein the rotation sensor comprises a piezoelectric sensor.

17. A drug delivery device, comprising: a device body; dose setting element attached to the device body and rotating relative to the device body around the rotation axis during dose delivery, the dose setting element contains a measured element, and the measured element contains surface details spaced in the radial direction from each other around the element rotation axis to set the dose; a dosing button attached to the body of the device, wherein the element to be measured is rotatable relative to the dosing button during dose delivery depending on the amount of dose delivered, the dosing button comprising a rotation sensor, the rotation sensor comprising a movable element mounted in sliding contact with surface parts during rotation of the measured element relative to the dispensing button during dose delivery, and the rotation sensor is configured to generate a signal in response to the movement of the movable element over the surface details during rotation of the element to set the dose, while the dosing button has a first position in which the movable the rotation sensor element is out of engagement with the surface features, and a second position where the rotation sensor movable element is in contact with the surface features; and a controller operatively coupled to the rotation sensor and located in the dispense button, wherein, in response to receiving a generated signal from the rotation sensor, the controller is configured to determine the number of surface features passing through the rotation sensor movable element during dose delivery, wherein when the dispense button is in the second position, the controller is configured immediately after receiving a signal indicating contact with the initial first one of the surface features, to activate the controller in a full power state, and the controller is configured immediately after receiving a signal indicating contact with the subsequent one of the surface features after the initial first surface feature, to determine the number of axially extending surface features passing the movable element of the rotation sensor during dose delivery.

18. The drug delivery device of claim 17, wherein the rotation sensor comprises a switch.

19. The drug delivery device of claim 17, wherein the rotation sensor comprises at least one contact.

20. The drug delivery device according to aspect 17, characterized in that the data

- 20 039524 The rotation dial contains a piezoelectric sensor.

21. The drug delivery device of claim 17, wherein the surface features extend axially from the dose setting element.

22. The drug delivery device according to any of the preceding aspects, further comprising a biasing element located in the axial direction between the dosing button and the dose setting element, while the rotation sensor and the controller are located in the cavity of the dosing button, and the surface parts are located inside the specified cavity in the radial direction outside the biasing element.

23. A drug delivery device according to any of the preceding aspects, characterized in that the body of the device contains a reservoir containing a drug.

Claims (17)

1. Device for drug delivery, containing: device body; a dose setting element attached to said device body and rotating relative to said device body about a rotation axis during dose delivery; a measurable element attached to said dose setting element and fixed thereon without the possibility of rotation, wherein said measurable element comprises axially extending surface features spaced radially apart from each other about an axis of rotation of said dose setting element; an actuator attached to said device body, wherein said measurable element is rotatable relative to said actuator during dose delivery depending on the amount of dose delivered; a rotation sensor attached to said actuator, wherein the rotation sensor comprises a switch, wherein the rotation sensor comprises a movable element mounted in sliding contact with axially extending surface features during rotation of said measurable element relative to said actuator during dose delivery, wherein said the rotation sensor is configured to generate a signal in response to actuation of the movable element over the axially extending surface features during rotation of said dose setting member, wherein the movable member alternately engaging or disengaging with the axially extending surface features details, configured to actuate the switch and generate the specified signal; and a controller operatively associated with the rotation sensor, wherein, in response to receiving a generated signal from said rotation sensor, the controller is configured to determine the number of axially extending surface features passing through the rotation sensor movable member during dose delivery. 2. A drug delivery device according to claim 1, characterized in that the axially extending surface features comprise alternating protrusions and recesses, while the movable element rests on the protrusions and recesses during rotation of the specified measurable element relative to the specified actuator during delivery doses. 3. A drug delivery device according to claim 2, characterized in that the protrusions extend proximally from said dose setting element. 4. A drug delivery device according to claim 3, characterized in that said dose setting element is a flange or dose setting element. 5. The drug delivery device according to claim 1, characterized in that said actuator has a first position in which the movable element of the rotation sensor is removed from interaction with the surface parts extending in the axial direction. 6. The drug delivery device according to claim 5, characterized in that said actuator has a second position in which the movable element of the rotation sensor contacts axially extending surface features. 7. The drug delivery device according to claim 6, characterized in that when said actuator is in the second position, the controller is configured immediately after receiving a signal indicating contact with an initial first one of said axially extending surface features, activating the controller in a full power state, wherein the controller is configured, immediately after receiving a signal indicating contact with a subsequent one of said axially extending surface features after the initial first surface feature, to determine the number of axially extending surface features passing through the movable rotation sensor element during dose delivery. 8. The drug delivery device according to claim 1, characterized in that the movable element contains at least one contact, with which, immediately after entering into mutual - 21 039524 interaction with axially extending surface parts, the movable element is capable of generating said signal. 9. The drug delivery device according to claim 8, characterized in that at least one contact contains a pair of contacts, while immediately after one of the pair of contacts has entered into interaction with an axially extending surface, the contact that has entered into interaction is movable into contact with another of the pair of contacts to generate the specified signal. 10. The drug delivery device according to claim 1, further comprising a module detachably attached to said actuator, the module comprising a movable element for engaging with a measurable element, said measurable element being outside the module. 11. Device for drug delivery, containing the body of the device; dose setting element attached to said device body and configured to rotate relative to said device body around an axis of rotation during dose delivery, said dose setting element comprising a measurable element, said measurable element comprising surface details spaced apart in the radial direction from each other around the axis of rotation of the specified element to set the dose; a dosing button attached to said device body, wherein said measurable element is rotatable relative to said dosing button during dose delivery depending on the amount of dose delivered, wherein the dosing button comprises a rotation sensor, said rotation sensor comprising a switch and a movable element , established with sliding contact with surface details during rotation of the specified measured element relative to the specified dispensing button during dose delivery, and the specified rotation sensor is configured to generate a signal in response to the movable element, which alternately enters into interaction or exits from interaction with surface details, when the movable element moves along the surface parts during the rotation of the specified element to set the dose, while the dosing button has a first position in which the movable element of the rotation sensor is removed from the interaction actions with surface features, and a second position in which the movable element of the rotation sensor contacts the surface features; and a controller operatively associated with the rotation sensor and located inside the dosing button, wherein, in response to receiving a generated signal from said rotation sensor, the controller is configured to determine the number of surface features passing through the rotation sensor movable element during dose delivery, wherein, when said dispensing button is in the second position, the controller is configured, immediately after receiving a signal indicating contact with the initial first one of said surface features, to activate the controller in a full power state, and wherein the controller is configured, immediately after receiving a signal indicating contact followed by one of said surface features, after the initial first surface feature, to determine the number of surface features passing through the movable element of the rotation sensor during dose delivery. 12. A drug delivery device according to claim 11, characterized in that the rotation sensor comprises at least one contact. 13. A drug delivery device according to claim 11, characterized in that the surface features extend axially from the dose setting element. 14. The drug delivery device according to claim 11, further comprising a biasing element located in the axial direction between the dosing button and the dose setting element, while the rotation sensor and the controller are located in the cavity of the dosing button, and the surface parts are located inside the specified cavity in radial direction outside the said biasing element. 15. The drug delivery device according to claim 1, where the rotation sensor is fixed on the actuator without the possibility of rotation and in the dose delivery mode the measured element rotates relative to the device body, and the actuator does not rotate relative to the device body. 16. The drug delivery device according to claim 11, where the rotation sensor is fixed on the dosing button without the possibility of rotation and in the dose delivery mode the measured element rotates relative to the device body, and the dosing button does not rotate relative to the device body. 17. A drug delivery device according to any one of the preceding claims, characterized in that the body of the device contains a reservoir containing a drug.